Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT02436486
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 76
Inclusion Criteria
- Body weight at least 50 kg and Body Mass index >18.5 and < 30 kg/m2
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination
- Use of contraception.
Exclusion Criteria
- The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit
- The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).
Other protocol defined inclusion and exclusion criteria do apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - Idalopirdine 120 mg ldalopirdine 120 mg Therapeutic dosages Moxifloxacin 400 mg Moxifloxacin 400 mg Positive Control Idalopirdine 360 mg Idalopirdine 360 mg Supra-therapeutic dosages
- Primary Outcome Measures
Name Time Method Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period For 24 hours in each dosing period The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FR801
🇫🇷Rennes, France